Confectionery compositions

ABSTRACT

Disclosed are stable portable oral care confectionery compositions which provide enhanced oral malodour benefits. Compositions of the present invention can optionally have one or more additional oral care benefits. The confectionery compositions comprise:  
     (i) greater than about 10 ppm of a first metal cation selected from the metals of groups 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 of the periodic table;  
     (ii) greater than about 10 ppm of a second metal cation different from the first metal cation and selected from the metals of groups 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 of the periodic table;  
     (iii) less than about 10% water; and  
     (iv) a confectionery carrier  
     wherein the ratio of the first metal cation to the second metal cation is in the range of from about 50:1 to about 1:50.

CROSS REFERENCE

[0001] This application claims priority under Title 35, United StatesCode 119(e) from Provisional Application Serial No. 60/291,178, filedMay 15, 2001.

FIELD OF THE INVENTION

[0002] The present invention relates to confectionery compositions thatcomprise a first metal cation and a second metal cation wherein theratio of the first metal cation to the second metal cation is in therange of from about 50:1 to 1:50 and wherein the composition comprisesless than 10% water. Preferably this invention relates to non-cariogenicor so called “sugar free” confectionery compositions. More particularlythis invention relates to portable oral care compositions that treat orprevent oral malodour. Compositions of the present invention aresuitable for use by humans or animals.

BACKGROUND OF THE INVENTION

[0003] Oral malodour or halitosis, which is commonly referred to as badbreath, is the result of volatile sulphur compounds, carboxylic acidsand amines building up in the oral cavity. The malodourous compounds aregenerated primarily through putrefactive action of oral micro organismson sulphur containing amino acids, peptones or proteins found in themouth. Such micro-organisms are readily available in saliva and dentalplaque and may be derived from proteinaceous food particles trappedbetween the teeth, in the gingival crevice or adhering to the mucousmembranes and the irregular surface of the tongue as well as exfoliatedoral epitheleum, food debris and the like. In addition oral malodour maybe the result of poor oral hygiene, digestive system problems, disease,diet or a combination of any of these factors. Not only is oral malodourunpleasant but its presence can be indicative of poor oral hygiene andcan also be one of the first signs of some more severe underlyingproblems. This is because the build up of putrid matter which causesmalodour can also lead to the formation of plaque, the origin of dentalcaries, gingivitis and dental calculus. Regular brushing of teeth canhelp to minimise oral malodour. However, even regular brushing is notsufficient to remove all of the food and oral bacteria deposits thatadhere to the oral surfaces and, in severe cases it is unable toeliminate oral malodour.

[0004] To date oral malodour products have been formulated to comprise awide range of materials that kill the oral bacteria contributing to theoral malodour. Such materials include agents such as triclosan,chlorhexidine, quaternary ammonium salts and camphoratedparachlorophenol. However, these materials can be harsh, and can only bedosed in limited daily amounts and as such are not necessarily suitablefor use in a product to be used several times a day. In some cases theymay also cause undesirable side effects such as staining, altered tasteetc.

[0005] More recently trends have been directed towards the use so callednatural materials, especially extracts, to provide a wide range ofbenefits in personal care products. Herbal extracts of gold thread andhoneysuckle have been reported (JP 57-85319/U.S. Pat. No. 5,741,138);herbal curry plant extract has been disclosed in JP 10-182,388 forcombating halitosis; cranberry extract has been disclosed in WO 96/28135for is antimicrobial and antibacterial properties; and DE 4,221,103discloses compositions comprising a wide range of herbal extracts fororal hygiene. Polyphenols have been identified as an important active ina wide range of herbal extracts. Examples of oral care disclosuresinclude WO 01/17494, which discloses dentifrice compositions comprisingtea polyphenols; US/PCT/00/11258 which discloses dentifrice compositionscomprising polyphenol herbal extracts; and EP 1,013,261 which disclosesa spray liquid comprising polyphenol for the masking of halitosis.Whilst the teachings of the prior art are directed towards compositionswith limited deodorising or anti-bacterial effects the productsthemselves have limited activity and are unstable leading tounattractive discolouration over time and further reduction in efficacy.There remains a need for a stable oral care product that is able todeliver effective malodour control benefits.

[0006] Metal cations have also been considered for inclusion in oralcompositions for treating oral malodour. Disclosures include U.S. Pat.No. 5,833,952 which discloses compositions comprising tin salts,optionally in combination with zinc salts; WO 99/17735 which discloses ametal ion amino acid chelate; U.S. Pat. No. 6,123,925 which discloses adentifrice comprising ceramic particles in combination withanti-microbial metal ions. However there remain several problems inpreparing compositions comprising metal ions for combating oralmalodour. These include that the presence of high level of metal cationcan often destabilise other elements of the composition, the metal ionsbecome easily chelated to other products and are therefore notefficacious, tightly controlled regulatory limits and the products tendto be highly astringent thus having unacceptable taste profiles. Despitethese disadvantages the use of metal cations for combating oral malodourhas several benefits. These include that the materials are very cheap,the materials are easy to work with and the metal cations have goodrecorded efficacy. Thus there remains a desire to continue to work withmetal cations to develop a stable, pleasant oral care product able todeliver effective and long lasting malodour benefits.

[0007] There is currently a movement in the oral care industry todevelop portable oral care product forms which can be used several timesa day, particularly after eating. It is hoped that such a product willimprove the oral hygiene of consumers. In addition, such a product wouldmake it easier to provide good oral hygiene to children and pets whereit is not always easy or possible to regularly brush the teeth.

[0008] Confectionery compositions which are popular with both childrenand adults alike and which are retained in the oral cavity forsubstantial periods of time during consumption, would seem to make anideal product form for a portable oral care product. The art of thedevelopment and manufacture of a wide range of confectionerycompositions is well known. However, the high sugar content of suchconfectionery compositions has been recognised as a contributory factorin poor dental health. Developments have been made to produce “sugarfree”, or non-cariogenic, confectionery which retain their organolepticproperties but which do not contribute to the formation of dentalplaque. More recently research has turned to developing confectionerycompositions, particularly “sugar free” confectionery compositions,particularly chewing gum compositions, which comprise one or more oralcare agents. One such example is WO 99/44436, which discloses coatedchewing gum compositions, which comprise materials with known oral carebenefits. However, although chewing gum products have severaladvantages, they also have several disadvantages in that the chewing ofgum is considered unsightly by some consumers and is not acceptable incertain societies. In addition, the chewing gum product format is notideal for administering to pets and children. As such there is a needfor a confectionery oral care product form, or range of forms, which areacceptable in a wide range of societies but which maintain high degreesof oral care efficacy, particularly anti-plaque and anti-calculusefficacy.

[0009] Surprisingly it has now been found that, when an oral compositionis prepared comprising a first metal cation and a second metal cationwherein the ratio of the first metal cation to the second metal cationis in the range of from about 50:1 to about 1:50 and wherein thecomposition comprises less than 10% water, a composition is obtainedwhich has effective oral malodour benefits. Furthermore, by formulatingthe product in a wide range of confectionery forms, portable oral care,which provides comparable benefits to frequent brushing, has beendeveloped which is acceptable to a wide range of consumers and culturesand in addition is in a form which is easily administered to pets andchildren.

[0010] Since the absolute levels of specific metal cations are oftencontrolled by tight regulations it can be difficult to formulate aproduct comprising sufficient metal cation to be efficacious. Thus bycombining two or more different metal cations in a single phasecomposition the level of active metal cation can be increased such thatthe product has the desired efficacy.

[0011] Furthermore it has been surprisingly found that when thecomposition comprises less than 10% water that the metal cations remainstably formulated within the composition and therefore retains theirefficacy. This low water level can also be exploited in terms ofcontrolled release. In such low water level products the metal cationsare added as solid salts, which are only solubilised once thecomposition comes into contact with saliva. Hence by using two or moredifferent salts with different solubility profiles a controlled releaseeffect of the metal cations can be achieved.

[0012] Ensuring that the ratio of the first metal cation to second metalcation is in the range of from about 50:1 to about 1:50 again ensuresthat each metal cation is present at a level to ensure that it has thedesired activity whilst ensuring that no single cation is present at alevel so high that it causes unpleasant negatives eg unacceptableastringency. In addition, the metal cations are thought to exhibit theiroral malodour effect by complexing with the volatile malodour producingcompounds to provide a long lasting bad breath reduction. By using acombination of more than one metal cation it is believed that there isan increases chance of enhancing the complexation of the volatilematerials and thus leading to more effective oral malodour controlbenefits. Finally, it is believed that the metal cations interact withthe oral microbes by inhibiting the cell activity and eventually killingthe organisms thus further reducing oral malodour and plaque. By using acombination of metal cations it is again believed that this effect isenhanced.

[0013] It is an object of this invention to provide a wide range of lowwater level confectionery compositions comprising a first metal cationand a different second metal cation such that the composition hasimproved and long lasting oral malodour benefits. It is another objectof this invention to provide oral compositions with reduced astringency.Finally it is an object of this invention to provide compositions thatare suitable for use by adults, children and pets. These and otherobjects of the present invention will become readily apparent from thedetailed description that follows.

SUMMARY OF THE INVENTION

[0014] The present invention relates to a confectionery compositioncomprising:

[0015] (i) greater than about 10 ppm of a first metal cation selectedfrom the metals of groups 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 of theperiodic table;

[0016] (ii) greater than about 10 ppm of a second metal cation differentfrom the first metal ion and selected from the metals of groups 5, 6, 7,8, 9, 10, 11, 12, 14, 16 of the periodic table;

[0017] (iii) less than about 10% water; and

[0018] (iv) a confectionery carrier

[0019] wherein the ratio of the first metal cation to the second metalcation is in the range of from about 50:1 to about 1:50.

DETAILED DESCRIPTION OF THE INVENTION

[0020] While the specification concludes with claims, which particularlypoint out and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description.

[0021] All documents cited are, in relevant part, incorporated herein byreference; the citation of any document is not to be construed as anadmission that it is prior art with respect to the present invention.

[0022] Herein, “comprising” means that other steps and other ingredientswhich do not affect the end result can be added. This term encompassesthe terms “consisting of” and “consisting essentially of”.

[0023] All percentages and ratios used herein are by weight of the totalcomposition and all measurements made are at 25° C., unless otherwisedesignated.

[0024] The term “safe and effective amount” as used herein means anamount of a compound, component, or composition sufficient tosignificantly induce a positive benefit, but low enough to avoid seriousside effects, i.e. to provide a reasonable benefit to risk ratio, withinthe scope of sound medical judgement.

[0025] The term “orally active” as used herein means a material thatprovides either a cosmetic, prophylactic or therapeutic benefit withinthe oral cavity.

[0026] The term “confectionery” as defined herein means a solid, gum,gum-like, or glassy composition optionally having a liquid centrefilling and/or optionally coated which comprises greater than about 25%sugar or sugar alcohol. Such compositions usually have a sweet taste.Examples of confectionery products include, but are not limited to,breath mints, low boiled candy, chewing gum, hard boiled candy, coatedcandy, lozenges, oral pasta, pressed mints, throat drops and the like.

[0027] The term “chewing gum” as defined herein means a confectionerycomposition which is suitable for chewing and which comprises 2% orgreater, by weight of the composition, of elastomer.

[0028] The term “elastomer” as defined herein means a non-digestiblepolymeric material, or mixture of materials, such as the materialstypically used in chewing gum compositions.

[0029] The term “crunchy” as defined herein means that the product has atexture such that has a firm and slightly gritty texture and whichproduces a slight cracking noise upon consumption. It is preferred thatthe compositions have a texture of granulated sugar.

[0030] Active and other ingredients useful herein may be categorised ordescribed herein by their cosmetic and/or therapeutic benefit or theirpostulated mode of action. However, it is to be understood that theactive and other ingredients useful herein can in some instances providemore than one therapeutic and/or cosmetic benefit or operate via morethan one mode of action. Therefore, classifications herein are made forthe sake of convenience and are not intended to limit an ingredient tothe particularly stated application or applications listed.

[0031] The elements of the compositions and methods of the presentinvention are described in more detail below.

[0032] First Metal Cation

[0033] Compositions of the present invention comprise greater than about10 ppm of a first metal cation. The metal cation is selected from themetals of group 5 (V, Nb, Ta); group 6 (Cr, Mo, W); group 7 (Mn, Tc,Re); group 8 (Fe, Ru, Os); group 9 (Co, Rh, Ir); group 10 (Ni, Pd, Pt);group 11 (Cu, Ag, Au); group 12 (Zn, Cd, Hg); group 14 (Ge, Sn, Pb);group 16 (Se, Te, PO); and mixtures thereof. Preferably the metal cationis selected from any monovalent or divalent cation selected from thegroup consisting of zinc, manganese, copper, iron, cobalt, silver,selenium, tin and vanadium; preferably from the group consisting ofzinc, manganese, copper, iron, silver, and tin; more preferably from thegroup consisting of zinc, copper, silver and tin and most preferablyfrom the group consisting of zinc and tin.

[0034] A wide variety of metal cation salts are useful in the presentinvention. These include so called “water-insoluble salts” which have asolubility of less than about 0.5 g per 100 ml at 25° C. and “watersoluble salts” which have a solubility of greater than or equal to about0.5 g per 100 ml at 25° C. It is also possible to use mixtures of thesesalts. Such mixtures can have several advantages in the compositions ofthe present invention since they are likely to have different complexingproperties with the polyphosphate anions. In addition they havedifferent release rates in the saliva and can therefore act to providecontrolled release profiles. Examples of salts that are suitable for useherein include acetate, ammonium sulphate, bromide, chloride, chromate,citrate, dithionate, fluorosilicate, tartrate, fluoride, formate,iodide, nitrate, phenol sulphate, salicyclate, sulphate, gluconate,succinate, glycerophosphate, lactate and mixtures thereof; preferred areacetate, bromide, chloride, citrate, dithionate, tartrate, fluoride,formate, iodide, nitrate, sulphate, gluconate, succinate, lactate andmixtures thereof; and more preferred are acetate, chloride, citrate,sulphate, gluconate, succinate, lactate and mixtures thereof. Ifstannous chloride is used it may be advantageous to premix the stannouschloride with sodium gluconate prior to incorporating the salt in thecomposition since this can help to stabilise the stannous ions.

[0035] Second Metal Cation

[0036] Compositions of the present invention also comprise greater thanabout 10 ppm of a second metal cation. The second metal cation can beselected from any of the materials outlined about for the first metalcation with the condition that the metal cation must differ from thatchosen for the first metal cation.

[0037] It is important that compositions of the present inventioncomprise levels of the first and second metal cations, and their salts,such that the composition complies with the local regulatory standards.These standards vary from one material to another and also from onecountry to another but would be known to one skilled in the art.Compositions of the present invention comprise greater than 10 ppm,preferably greater than 15 ppm, more preferably greater than 20 ppm,even more preferably greater than 25 ppm of the orally active metalcation. Compositions of the present invention preferably comprise fromabout 0.001% to about 5%, preferably from about 0.01% to about 2%, morepreferably from about 0.1% to about 1% and most preferably from about0.1% to about 0.5%, by weight of the composition, of metal saltcomprising the orally active metal cation. In order to maximise thebenefits of the combination of two metal cations the molar ratio of thefirst metal cation to the second metal cation should be in the range offrom about 50:1 to about 1:50, preferably of from about 20:1 to about1:20 and more preferably of from about 10:1 to 1:10.

[0038] Water

[0039] Compositions of the present invention comprise less than about10%, preferably less than about 8%, more preferably less than about 5%,even more preferably less than about 3%, and most preferably less thanabout 2%, by weight of the composition, water. The low levels of waterare required in order to ensure that the polyphenol components of theplant extracts are not oxidised and, if included, any long chainpolyphosphates are not hydrolysed in the final composition.

[0040] Water used in the preparation of commercially suitablecompositions should preferably be of low ion content and free of organicimpurities. The amount of water in a composition should be considered tobe not only that added as free water, but also water which is introducedwith other materials, such as with sorbitol, silica, surfactantsolutions and/or colour solutions. Furthermore the amount of watershould be considered by weight of the final composition as a wholeincluding coat and/or filling, where appropriate.

[0041] Confectionery Carrier Material

[0042] Compositions of the present invention are confectionerycompositions including chewing gum. Suitable physical forms includesticks, dragees, chicklets, and batons. Although the exact ingredientsfor each product form will vary from product to product, the specifictechniques will be known by one skilled in the art. However there aresome general ingredients which are common to all product forms and theseare discussed in more detail below. Preferred product forms are pressedtablets, low boiled candy, hard boiled candy and chewing gum which arereadily formulated with less than about 10%, by weight of thecomposition, water.

[0043] Confectionery compositions of the present invention comprise acarrier material. The carrier materials vary depending on the type ofconfectionery used and would be well known to one skilled in the art.The carrier material can be chosen from chewable or non chewblematerials. It is referred that the compositions comprise at least 10%chewable material. The chewable material can be selected from gumsincluding agar agar gum, gelatine etc; low boiled sugar candy base andgum base materials. It is preferred that the carrier material forcompositions of the present invention are not in the form of a whippableor aerated emulsion. Hard and low boiled candy carrier, pressed tabletsand the like usually comprise greater than about 70% bulk sweetenerincluding suitable sugar and sugar syrups including cariogenic andnon-cariogenic materials. Low boiled candies can also comprise butter toform chewable toffee. For jelly and gum drop compositions the carriercomprises greater than about 25% bulk sweetener and additionallycomprise gums including gum arabic, gelatine, agar agar powder and thelike.

[0044] Compositions of the present invention are preferably in the formof a chewing gum. As such it is preferred that the compositions comprisegreater than about 10%, preferably greater than about 15%, morepreferably greater than about 20% and most preferably greater than about25% up to about 75%, by weight of the composition, of gum base. The gumbase comprises a carrier material, or mixture of carrier materials,selected from elastomers, resins or waxes. The gum base carriermaterials are water insoluble materials which are typically not releasedin the mouth. Such materials include:

[0045] (i) Elastomers and Elastomer Solvents

[0046] Compositions of the present invention preferably comprise anelastomer, or mixture of several different elastomers. Elastomericmaterials are generally known in the art but illustrative examplesinclude styrene-butadiene rubber (SBR), synthetic gums; polyisobutyleneand isobutylene-isoprene copolymers; natural gums; chicle; naturalrubber; jelutong; balata; guttapercha; lechi caspi; sorva; and mixturesthereof. Compositions of the present invention preferably comprise fromabout 2% to about 30%, more preferably from about 5% to about 25%, byweight, of elastomer. These levels are determined by the desired finaltexture of the chewing gum since when the total level of elastomer isbelow about 2% the base composition lacks elasticity, chewing texture,and cohesiveness whereas at levels above about 30% the formulation ishard, rubbery and maintains a tight chew.

[0047] Elastomer solvents are also preferably present in compositions ofthe present invention since they aid softening of the elastomercomponent. Preferred examples of elastomer solvents for use hereininclude the pentaerythritol ester of partially hydrogenated wood rosin,pentaerythritol ester of wood rosin, glycerol ester of partiallydimerized rosin, glycerol ester of polymerised rosin, glycerol ester oftall oil, wood or gum rosin, glycerol ester of partially hydrogenatedrosin, methyl ester of partially hydrogenated rosin, and mixturesthereof. Compositions of the present invention preferably comprise fromabout 2% to about 50%, more preferably from about 10% to about 35%, byweight, of elastomer solvent.

[0048] (ii) Resins and Waxes

[0049] Resins are an optional, but desirable, ingredient of chewing gumcompositions herein. They serve to plasticise the gum base. Suitableresins include polyvinyl acetate (PVA); terpene resins, includingpolyterpene and polymers of alpha-pinene or beta-pinene; and mixturesthereof. Such compositions preferably comprise from about 3% to about25%, preferably from about 5% to about 20%, by weight, of resin.

[0050] The chewing gum compositions may also include one or more waxes.Suitable waxes include paraffin wax; microcrystalline wax;Fischer-Tropsch paraffin; natural waxes such as candellilla, carnaubaand beeswax; polyolefin waxes such as polyethylene wax; and mixturesthereof. Compositions comprise up to about 25%, preferably from about 5%to about 20%, by weight, of wax.

[0051] Confectionery compositions of the present invention can be centrefilled. Such products preferably comprise from about 60% to about 95%,more preferably from about 75% to about 85% of an edible shell and fromabout 5% to about 40%, preferably from about 15% to bout 25%, by weightof the composition, of an edible filling. It is possible that centrefilled confectionery composition can comprise an oral care active in theedible shell and or a different oral care active, or mixture of actives,in the edible filling. In addition the composition can comprisedifferent flavouring agents in the shell and the filling.

[0052] Compositions of the present invention may comprise one or morecrunchy solid particles dispersed throughout the carrier material. Thecrunchy preferably particle has a minimum particle size such that theparticles are retained by a 0.1 mm mesh, preferably a 0.112 mm mesh,more preferably a 0.16 mm mesh, even more preferably a 0.18 mm mesh andmost preferably a 0.2 mm mesh wherein the meshes are selected from theDIN 4188 mesh series. Furthermore the particle preferably has a maximumparticle size such that it passes through a 2 mm mesh, preferably a 1 mmmesh, more preferably an 0.8 mm mesh, even more preferably a 0.5 mm meshand most preferably a 0.4 mm mesh, again wherein the meshes are selectedfrom the DIN 4188 mesh series. The solubility of the particle ispreferably at least 1 g per 100 ml at 25° C., more preferably at least 5g, even more preferably at least 8 g and most preferably at least 15 gper 100 ml at 25° C. Finally it is preferred that the particulatematerial has a hardness of greater than 1, preferably greater than 2 onthe Mohs hardness scale. The particle size, solubility and hardnessproperties confer a crunchy texture to the confectionery itself. Suchparticles can be present as solid forms of one of the oral care activesoutlined above, in the case where the oral care active is a solid, orcan be a further particle such as sugar crystals, dried fruits, nuts,etc. The crunchy texture can be used to reinforce the oral care benefitsto the consumer. Different crunchy textures can be obtained by millingthe particles to the desired size or by blending different commercialgrades of particles to achieve the desired crunch. It is preferred thethat crunchy sensation remains consumer noticeable for at least 1 minute30 seconds, preferably for at least 2 minutes and more preferably for atleast 2 minutes 30 seconds. However it is also preferred that thecrunchy texture has disappeared by 5 minutes, preferably by 4 minutes sothat the material does not abrade the dentin or so that the product doesnot have a gritty residue.

[0053] Furthermore the confectionery compositions of the presentinvention can also be coated. The outer coating may be hard or crunchy.Typically, the outer coating will essentially consist of sorbitol,maltitol, xylitol, isomalt, and other crystallisable polyols.Furthermore the coating will typically consist of several opaque layers,such that the confectionery core is not visible through the coatingitself, which can optionally be covered with a further one or moretransparent layers for aesthetic, textural and protective purposes. Theouter coating may also contain small amounts of water and gum arabic. Apolyol coating can be further coated with wax. The coating is applied ina conventional manner by successive applications of a coating solution,with drying in between each coat, as described in WO99/44436. As thecoating dries it usually becomes opaque and is usually white, thoughother colorants may be added. A polyol coating can be further coatedwith wax. The coating can further comprise coloured flakes or speckles.If the composition comprises a coat it is possible that one or more ofthe oral care actives can be dispersed throughout the coat. This isespecially preferred if one or more oral care active is incompatible ina single phase composition with another of the actives. It is preferredthat compositions of the present invention comprise the polyphosphatedispersed throughout the core and the metal cation dispersed throughoutthe coat.

[0054] Balance of the Composition

[0055] Compositions of the present invention preferably comprise safeand effective levels of one or more additional components. Suchmaterials are well known and are readily chosen by one skilled in theart based on the oral care, physical and aesthetic properties desiredfor the compositions being prepared. Examples of such materials include,but are not limited to fats, solvents, waxes, emulsifiers, softeners,bulking agents, cationic material, buffers, whitening agents, alkalimetal bicarbonate salts, thickening materials, humectants, water,surfactants, titanium dioxide, flavouring agents, colouring agents, andmixtures thereof. Those ingredients most commonly used are described inmore detail below.

[0056] Oral Care Active

[0057] Compositions of the present invention comprise an oral careactive selected from the group consisting of anti-calculus agents;anti-plaque agents; fluoride ion source; desensitising agents; oralmalodour control agents; H2 antagonists; and mixtures thereof.Preferably the oral care active is selected from the group consisting ofanti-calculus agents; the group of anti-plaque agents; the group ofdesensitising agents; oral malodour control agents; more preferably theoral care active is an anti-calculus agent; more preferably the oralcare active is polyphosphate. It is not intended that the actives listedin groups below are mutually exclusive and a single active may beincluded in compositions of the present invention to have severaleffects.

[0058] Compositions of the present invention preferably comprise fromabout 0.01% to about 50%, more preferably from about 0.1% to about 15%,even more preferably from about 0.25% to about 10%, and most preferablyfrom about 0.5% to about 7%, by weight, of oral care active.

[0059] Anti-calculus Agents: Anti-calculus agents known for use indental care products include phosphate, pyrophosphate, polyphosphate,phosphonate, polyphosphonate and mixtures thereof. Pyrophosphates areamong the best known for use in dental care products. The pyrophosphatesalts useful in the present compositions include the dialkali metalpyrophosphate salts, tetra-alkali metal pyrophosphate salts and mixturesthereof in their unhydrated as well as hydrated forms are the preferredspecies. Disodium dihydrogen pyrophosphate (Na₂H₂P₂O₇), tetrasodiumpyrophosphate (Na₄P₂O₇), and tetrapotassium pyrophosphate (K₄P₂O₇) andmixtures thereof. The pyrophosphate salts are described in more detailin Kirk and Othmer, Encyclopeadia of Chemical Technology, 3^(rd)Edition, Volume 17, Wiley Interscience Publishers (1982).

[0060] Polyphosphates are the preferred anti-calculus agents for useherein. Polyphosphate is a widely used term which relates to phosphateanions which have been polymerised by dehydration to form a polymer ofthe phosphate anion. The polyphosphates can exist as linear or cyclicmaterials or mixtures thereof. It is preferred that the polyphosphatesare linear materials comprising only low levels of cyclic materials.Polyphosphates are also characterised by the average anion chain lengthof the polymer. For the purposes of this invention the polyphosphatesreferred to are those with an average anion chain length of 3 orgreater. It is preferred that the polyphosphates have an average anionchain length of from about 3 to about 40, preferably of from about 6 toabout 30; more preferably of from about 10 to about 25 and even morepreferably of from about 18 to about 25, and mixtures thereof.Furthermore polyphosphates exist as salts. It is preferred that thepolyphosphate is an alkali metal salt, ammonium salt or mixturesthereof, preferably a sodium or potassium salt or mixtures thereof andmore preferably a sodium salt. Polyphosphates with an average anionchain length of greater than four usually occur as glassy materials. Asdefined herein a “glassy” material is one which is amorphous. Preferredin this invention are the linear “glassy” polyphosphates having theformula:

XO(XPO₃)_(n)X

[0061] wherein X is sodium, potassium, or hydrogen and n averagesgreater than or equal to 6 or mixtures thereof. Such polyphosphates aremanufactured by FMC Corporation and are commercially known as Sodaphos(n≈6), Hexaphos (n≈13), and Glass H (n≈21). Hexaphos and Glass H arepreferred with Glass H being the most preferred polyphosphate. Thesepolyphosphates may be used alone or in combination. A broad range ofphosphates and their sources are described in Kirk & Othermer,Encyclopedia of Chemical Technology, Fourth Edition, Volume 18,Wiley-Interscience Publishers (1996), incorporated herein by referencein its entirety, including all references incorporated into Kirk &Othermer. Compositions of the present invention preferably comprisegreater than about 1%, preferably from about 1.5% to about 50%, morepreferably from about 2% to about 15%, even more preferably from about3% to about 12%, and most preferably from about 5% to about 10%, byweight, of polyphosphate salt.

[0062] It may be desirable to have a sustained release of thepolyphosphate agent from the confectionery composition. This may beaccomplished by incorporating into the composition a furtherpolyphosphate material, particularly a divalent cationic salt such as acalcium salt, which has a lower aqueous solubility than the majorpolyphosphate material. This can be used to tailor the release rate ofpolyphosphate to a required profile. By weight percent, thepolyphosphate of lower solubility is generally present in no more thanhalf, preferably no more than a quarter of the level of the more solublematerial. For example, the cationic material lower solubilitypolyphosphate is typically present in an amount of up to about 10%,preferably from about 0.05% to about 5%, and more preferably from about0.1% to about 3%, by weight of the composition. Incorporating apolyphosphate into compositions of the present invention has anadditional benefit of reducing the astringency of the metal cationswithin the composition thus improving the taste. In order to maximisethis benefit the molar ratio of polyphosphate anion to the total levelof metal cation should be in the range of from about 10:1 to about 1:1,preferably from about 5:1 to about 1:1, preferably from about 3:1 toabout 1:1. As used herein the term “polyphosphate anion” refers to asingle anion regardless of chain length. The level of polyphosphateanion should be calculated by assuming that all of the polyphosphatematerial has the chain length of the average anion chain length of thematerial as quoted by the manufacturer.

[0063] Additional anti-calculus agents include polyacrylates and otherpolycarboxylates such as those disclosed in U.S. Pat. No. 3,429,963issued to Shedlovsky on Feb. 25, 1969 and U.S. Pat. No. 4,304,766 issuedto Chang on Dec. 8, 1981; and U.S. Pat. No. 4,661,341 issued to Benedictand Sunberg on Apr. 28, 1987; polyepoxysuccinates such as thosedisclosed in U.S. Pat. No. 4,846,650 issued to Bendict, Bush and Sunbergon Jul. 11, 1989; ethylenediaminetetraacetic acid as disclosed inBritish Patent No 490,384 date Feb. 15, 1937; nitrilotriacetic acid andrelated compounds as disclosed in U.S. Pat. No. 3,678,154 issued toWidder and Briner on Jul. 18, 1972; polyphosphonates as disclosed inU.S. Pat. No. 3,737,533 issued to Francis on Jun. 5, 1973; U.S. Pat. No.3,988,443 issued to Ploger, Schmidt-Dunker and Gloxhuber on Oct. 26,1976 and U.S. Pat. No. 4,877,603 issued to Degenhardt and Kozikowski onOct. 31, 1989. Anticalculus phosphates include potassium and sodiumpyrophosphates; sodium tripolyphosphate; diphosphonates such asethane-1-hydroxy-1,1-diphosphonate, 1-azacycloheptane-1,1-diphosphonate,and linear alkyl diphosphonates; linear carboxylic acids; and sodiumzinc citrate and other soluble zinc salts.

[0064] Anti-plaque Agents: Anti-plaque agents include anti-plaque agentsand flouride ion sources. Anti-plaque agents are any substances whichinhibit the accumulation of bacterial deposits on the surfaces of theoral cavity. Examples include xylitol and other anti-microbial agents.

[0065] Fluoride Ion Source: Application of fluoride ions to dentalenamel serves to protect teeth against decay. A wide variety of fluorideion yielding materials can be employed as sources of soluble fluoride inthe present compositions. Examples of suitable fluoride ion yieldingmaterials are found in U.S. Pat. No. 3,535,421, Oct. 20, 1970 issued toBriner et al. and U.S. Pat. No. 3,678,154 Jul. 18, 1972 issued to Widderet al. Preferred fluoride ion sources for use herein include sodiumfluoride, potassium fluoride, stannous fluoride, ammonium fluoride andmixtures thereof. Sodium fluoride is particularly preferred. Preferablythe present composition provide from about 50 ppm to about 10,000 ppm,more preferably from about 100 ppm to about 3000 ppm of fluoride ions.

[0066] Desensitising Agents: Desensitising agents, or anti-pain agents,can also be present in the oral care compositions or substances of thepresent invention. Such agents may include, but are not limited to,strontium chloride, potassium nitrate, natural herbs such as gall nut,Asarum, Cubebin, Galanga, scutellaria, Liangmianzhen, Baizhi, etc.Analgesics, including low levels of non-steroidal anti-inflammatoryagents, such as ketorolac, flurbinprofen, ibuprofen, naproxen,indomethacin, aspirin, ketoprofen, piroxicam and meclofenamic acid, mayalso be used as desensitising agents.

[0067] Oral Malodour Control Agents: Oral malodour control agentsinclude a wide variety of materials. The most commonly used areantimicrobial agents can also be present in the oral care compositionsor substances of the present invention. Such agents may include, but arenot limited to, 5-chloro-2-(2,4-dichlorophenoxy)phenol, commonlyreferred to as triclosan, and described in the Merck Index, 11^(th)Edition, (1989), pp1529 (entry no 9573) in U.S. Pat. No. 3,506,720, andin European Patent Application No 0,251,591 of Beecham Group, Plc,published Jan. 7, 1988; phthalic acid and its salts including, but notlimited to those disclosed in U.S. Pat. No. 4,994,262 published Feb. 19,1991, preferably magnesium mono-potassium phthalate, chlorhexidine(Merck Index, no 2090); alexidine (Merck Index, no 222); hexetidine(Merck Index, no 4624); sanguinarine (Merck Index, no 8320);benzalkonium chloride (Merck Index, no 1066); salicylanilide (MerckIndex, no 8299); domiphen bromide (Merck Index, no 3411);cetylpyridinium chloride (CPC) (Merck Index, no 2024);tetradecylpyridinium chloride (TPC); N-tetradecyl-4-ethylpyridiniumchloride (TDEPC); octenifine; delmopinol; octapinol; and otherpiperidine derivatives; nicin preparations; zinc/stannous ion agents;antibiotics such as augmentin, amoxicilline, tetracycline, doxycycline,minocycline, and metronidazole; and analogues and salts of the above;methyl salicyclate; and mixtures of all of the above.

[0068] A second class of materials are the anti-bacterial natural plantextracts. These extracts include extracts obtained from any part of theplant including the leaf, stern, bark, pulp, seed, flesh, juice, rootand mixtures thereof. It is preferred that the extract is obtained fromthe leaf, pulp and seed, more preferably from the leaf or seed. Manydifferent plants, or parts of plants, can be used to provide theseextracts including tea, especially green tea, magnolia, gold thread,honeysuckle, grape, bergamot, grapefruit, orange, lemon, tangerine,mandarin, satsuma, clementine, lime, and mixtures thereof; preferablyfrom grape, grapefruit and mixtures thereof. Such extracts comprise awide variety of biologically active materials. These includeanthocyanins, flavanols, hydrolysable tannins, alkaloids, lipids,carbohydrates, simple sugars, protein and amino acids, alcohols,polyphenols, organic acids and mixtures thereof. Essential oils are alsoknown to have anti-bacterial properties. These include thymol, geraniol,carvacrol, hinokitiol, eucalyptol, catechol (particularly 4-allylcatechol) and mixtures thereof. It is preferred that compositions of thepresent invention comprise from about 0.0001% to about 30%, preferablyfrom about 0.001% to about 15%, more preferably from about 0.01% toabout 10%, even more preferably from about 0.1% to about 5% and mostpreferably from about 0.25% to about 3%, by weight of the composition,of extract.

[0069] Compositions of the present invention may optionally comprisezinc phytate in combination with natural extracts. The zinc phytate isbelieved to enhance the polyphenol breath protection efficacy andincrease the stability of the polyphenol extract. Compositions of thepresent invention preferably comprise from about 0.1% to about 10%, morepreferably from about 0.5% to about 5% and most preferably from about 1%to about 3%, by weight of the composition, of zinc phytate.

[0070] Another class of oral malodour control agents include absorbents.These are used to absorb, adsorb, bind or otherwise complex the volatileoral malodour materials. Examples of such agents include talc, mushroomextract, zeolite, cyclodextrin, silica shell and mixtures thereof. Suchmaterials are preferably used at a level of from about 0.5% to about10%, preferably from about 1% to about 5%, by weight of the composition.

[0071] H-2 Antagonists: Histamine-2 (H-2) receptor antagonist compounds(H-2 antagonists) may be used in the oral care compositions of thepresent invention. As used herein, selective H-2 antagonists arecompounds that block H-2 receptors, but do not have meaningful activityin blocking histamine-1 (H-1) receptors. Selective H-2 antagonistsinclude those disclosed in U.S. Pat. Nos. 5,294,433 and 5,364,616 Singeret al., issued Mar. 15, 1994 and Nov. 15, 1994 respectively and assignedto Procter & Gamble, wherein the selective H-2 antagonist is selectedfrom the group consisting of cimetidine, etintidine, ranitidine,ICIA-5165, tiotidine, ORF-17578, lupitidine, donetidine, famotidine,roxatidine, pifatidine, lamtidine, BL-6548, BMY-25271, zaltidine,nizatidine, mifentidine, BMY-52368, SKF-94482, BL-6341A, ICI-162846,ramixotidine, Wy-45727, SR-58042, BMY-25405, loxtidine, DA-4634,bisfentidine, sufotidine, ebrotidine, HE-30-256, D-16637, FRG-8813,FRG-8701, impromidine, L-643728 and HB-408. Particularly preferred iscimetidine (SKF-92334),N-cyano-N′-methyl-N″-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine:

[0072] Cimetidine is also disclosed in the Merck Indes, 11^(th) editions(1989), p354 (entry no 2279), and Physicians' Desk Reference, 46^(th)edition (1992), p2228. Related preferred H-2 antagonists includeburimamide and metiamide.

[0073] Antioxidants: Antioxidants are generally recognised as useful incompositions such as those of the present invention. Antioxidants aredisclosed in texts such as Cadenas and Packer, The Handbook ofAntioxidants, © 1996 by Marel Dekker, Inc. Antioxidants that may beincluded in the oral care compositions of the present invention include,but are not limited to, Vitamin E, ascorbic acid, Uric acid,carotenoids, Vitamin A, flavenoids and polyphenols, herbal antioxidants,melatonin, aminoindoles, lipoic acids and mixtures thereof.

[0074] Teeth Colour Modifying Substances: Teeth colour modifyingsubstances may be considered among the oral care actives useful in thepresent invention. These substance are suitable for modifying the colourof the teeth to satisfy the consumer such as those listed in the CTFACosmetic Ingredient Handbook, 3^(rd) Edition, Cosmetic and FragrancesAssociation Inc., Washington DC (1982), incorporated herein byreference. Specific examples include talc, mica, magnesium carbonate,calcium carbonate, magnesium silicate, aluminium magnesium carbonate,silica, titanium dioxide, zinc oxide, red iron oxide, brown iron oxide,yellow iron oxide, black iron oxide, ferric ammonium ferrocyanide,manganese violet, ultramarine, nylon powder, polyethylene powder,methacrylate powder, polystyrene powder, silk powder, crystallinecellulose, starch, titanated mica, iron oxide titanated mica, bismuthoxychloride, and mixtures thereof. Typical pigment levels from about0.05% to about 20%, preferably from about 0.1% to about 15% and mostpreferably from about 0.25% to about 10%, by weight, of the composition.

[0075] Compositions for use herein may also comprise materials thatremove or bleach intrinsic or extrinsic stains on or in tooth surfaces.Such substance are selected from the group consisting of the peroxides,metal chlorites, perborates, percarbonates, peroxyacids, persulphates,and combinations thereof. Suitable peroxide compounds include hydrogenperoxide, urea peroxide, calcium peroxide, carbamide peroxide andmixtures thereof. Suitable metal chlorites include calcium chlorite,barium chlorite, magnesium chlorite, lithium chlorite, sodium chloriteand potassium chlorite. Additional bleaching substances may behypochlorite, and chlorine dioxide. A preferred percarbonate is sodiumpercarbonate. Preferred persulphates are oxones. The level of thesesubstances is dependent on the available oxygen or chlorine. This levelis generally used in compositions of the present invention at levelsfrom about 0.1% to about 35%, preferably from about 1% to about 25% andmost preferably from about 5% to about 10%, by weight of thecomposition.

[0076] Nutrients

[0077] Nutrients may improve the condition of the oral cavity and can beincluded in the oral care compositions or substances of the presentinvention. Nutrients include minerals, vitamins, oral nutritionalsupplements, enteral nutritional supplements, herbal supplements,natural extracts and mixtures thereof as disclosed in Drug Facts andComparisons (loose leaf drug information service), Wolters KluerCompany, St Louis, Mo., ©1997. Minerals that can be included with thecompositions of the present invention include calcium, phosphorus,fluoride, zinc, manganese, potassium and mixtures thereof. Vitamins canbe included with minerals or used separately. Vitamins include VitaminsC and D, thiamine, riboflavin, calcium pantothenate, niacin, folic acid,nicotinamide, pyridoxine, cyanocobalamin, para-aminobenzoic acid,bioflavonoids, and mixtures thereof. Fish oil contains large amounts ofOmega-3 (N-3) polyunsaturated fatty acids, eicosapentaenoic acid anddocosahexaenoic acid.

[0078] Sweeteners

[0079] Two main types of sweeteners exist; bulk sweeteners and highintensity sweeteners. In general, the amount of sweetener used will varydepending on the sweetener and the overall desired aesthetics but levelsused should be high enough such that the desired level of sweetness isachieved independent from the flavour. When bulk sweeteners are usedthey can also assume the role of the bulking agent or filler within thecomposition.

[0080] Bulk Cariogenic Sweetener: Compositions of the present inventionmay comprise sweetener materials. Such materials includemonosaccharides, disaccharides, polysaccharides and mixtures thereof.Examples include xylose, ribose, glucose, mannose, galactose, fructose,dextrose, sucrose, sugar maltose, fructo oligo saccharide syrups,partially hydrolysed starch, or corn syrup solids and mixtures thereof.However, such materials can often lead to the formation of cavitiessince they are readily metabolised by bacteria and other micro-organismsin the oral cavity. It is preferred that compositions of the presentinvention comprise less than about 10%, preferably less than about 5%,more preferably less than about 2%, even more preferably less than about1%, and most preferably less than about 0.5%, by weight of thecomposition, of cariogenic sweetener. Compositions of the presentinvention can comprise 0% cariogenic sweetener if desired.

[0081] Bulk Non Cariogenic Sweeteners: Compositions of the presentinvention preferably comprise a non-cariogenic sweetener. As used hereinthe term “non-cariogenic” refers to sweeteners which are not able to bemetabolised by oral microbes and therefore do not contribute to theformation of dental caries. It is preferred that compositions of thepresent invention comprise greater than about 10%, preferably greaterthan about 20%, more preferably greater than about 30% and mostpreferably greater than about 40%, by weight of the composition, of noncariogenic sweetener. Compositions of the present invention can compriseup to about 99%, by weight of the composition, of non-cariogenicsweetener if desired.

[0082] Preferred bulk non cariogenic sweetening agents are sugaralcohols such as sorbitol, xylitol, mannitol, maltitol, isomalt,hydrogenated starch hydrolisate, insulin, and other non-carigenic ediblepolyols such as glycerin and erythritol and mixtures thereof. Mostpreferred are non cariogenic sweeteners selected from the groupconsisting of maltitol, mannitol, xylitol, sorbitol, sucralose,aspartame and its salts, and mixtures thereof. In general compositionscomprise from about 10% to about 80%, more preferably from about 30% toabout 70%, by weight, of bulk sweetener.

[0083] High Intensity Sweeteners: High intensity sweeteners arepreferred over bulk sweeteners for use in compositions of the presentinvention because, for among other reasons, high intensity sweetenersmay prolong the flavour of the finished gum composition during chewing.Suitable high intensity sweeteners include: dipeptide based sweetenerssuch as L-aspartyl-L-phenylalanine methyl ester (Aspartame) andequivalents (described in U.S. Pat. No. 3,492,131),L-α-aspartyl-N-(2,2,4,4-tetramethyl-3-thietanyl)-D-alaninamide hydrate(Alitame) and the like; saccharin and its soluble salts eg sodium orcalcium saccharin salts; cyclamate salts for example acesulfame-K andthe like; chlorinated derivatives of sucrose such as chlorodeoxysucroseand the like; and protein based sweeteners, such as Thaumatin (talin).Compositions of the present invention preferably comprise from about0.01% to about 2.0%, more preferably from about 0.05% to about 0.5%, byweight, of high intensity sweetener.

[0084] Bulking Agents

[0085] Bulking agents, such as fillers, can also be employed inconfectionery. Suitable fillers and bulking agents are generallynon-abrasive, preferably with an average particle size less than 5 μm,more preferably less than 3 μm and especially less than 1 μm.Illustrative bulking agents include calcium carbonate or groundlimestone, talc, aluminium hydroxide, alumina, aluminium silicates,dicalcium phosphate and mixtures thereof. Compositions preferablycomprise up to about 50%, more preferably up to about 30%, and mostpreferably up to about 10%, by weight, of bulking agent.

[0086] Additional Chewing Gum Ingredients

[0087] There are several ingredients which are commonly added to chewinggum compositions and which are not commonly used in other types ofconfectionery. Examples of materials are listed below but this list isnot to be considered limiting. Similarly such ingredients can be used inother types of confectionery if desired.

[0088] Chewing gum compositions of the present invention may alsocomprise plasticisers in addition to the resin component. Suitableplasticisers include glyceryl triacetate, acetylated monoglyceride,glyceryl tributyrate, ethyl laurate, ethyl acetoacetate, diethyltartrate, ethyl or butyl lactates, diethyl malate, ethyl oleate, castoroil, succinylated monoglycerides or mixtures thereof. Glyceryltriacetate and acetylated monoglyceride are preferred. Compositionspreferably comprise up to about 10%, preferably from about 0.1% to about3%, by weight, of plasticiser.

[0089] Compositions of the present invention preferably comprise asoftener or mixture of softeners which, when incorporated into the gumbase, assist in modifying the texture and consistency properties. Inparticular, they help to soften the chew and to maintain chew softnessover an extended period of time. Suitable softeners include fattymaterials such as lanolin, stearic acid, sodium stearate and potassiumstearate; polyhydric alcohols such as glycerine, propylene glycol, andthe like; and mixtures thereof. Compositions preferably comprise up toabout 30%, more preferably from about 0.1% to about 10%, by weight, ofsoftener. In a preferred embodiment, the chewing gum compositioncomprises from about 0.1% to about 10%, by weight, of a fatty softenerselected from stearic acid, sodium stearate, potassium stearate andmixtures thereof, preferably stearic acid.

[0090] The chewing gum compositions preferably comprise an emulsifiersuch as glycerol monostearate, lecithin, fatty acid monoglycerides,diglycerides, propylene glycol monostearate and mixtures thereof.Compositions comprise up to about 10%, and preferably from about 2% toabout 6%, by weight, of emulsifier.

[0091] Various fats can also be included in the chewing gum compositionsof the present invention. Preferred fats include the hydrogenatedvegetable oils such as hydrogenated palm oil, hydrogenated soybean oil,hydrogenated cotton seed oil and various other hydrogenated vegetableoils and mixtures thereof. The fats can suitably be used at a level upto about 20%, preferably from about 1% to about 10%, by weight, of thechewing gum composition.

[0092] Flavouring Agents

[0093] Compositions of the present invention can preferably comprise aflavouring agent. As used herein the term “flavouring agent” means thoseflavour essences and equivalent synthetic materials which are added toflavour the composition. The flavouring agent can also include specificmaterials, hich are added to provide a warming or cooling sensation.

[0094] Flavouring agents are well known in the art. They includesynthetic flavours and or oils and or essences derived from plants,roots, beans, nuts, leaves, flowers, fruits and so forth and mixturesthereof. Examples of suitable flavours include lemon, orange, banana,grape, lime, apricot, grapefruit, apple, strawberry, cherry, chocolate,pineapple, coffee, cocoa, cola, peanut, almond, liquorice, cinnamon andthe like. The amount of flavouring agent employed is normally a matterof preference but in general they are used in amounts up to about 4%,preferably from about 0.1 to about 1%, by weight of the composition.

[0095] Compositions of the present invention can optionally comprise acooling agent and suitable materials are described in WO 97/06695.Preferred for use herein are physiological cooling agents selected fromthe group consisting of menthol, peppermint oil,N-substituted-p-menthane-3-carboxamides, acyclic tertiary and secondarycarboxamides, 3-1-methoxy propan-1,2-diol and mixtures thereof.Particularly preferred are menthol and menthol containing oils such aspeppermint oil. Cooling agents are preferably used at a level of fromabout 0.001 to about 5%, more preferably from about 0.05% to about 3.5%,by weight of the composition.

[0096] Compositions of the present invention can optionally comprise awarming agent. Preferred agents include those selected from the groupconsisting of vanillyl alcohol n-butyl ether, vanillyl alcohol n-propylether, vanillyl alcohol isopropyl ether, vanillyl alcohol isobutylether, vanillyl alcohol n-amino ether, vanillyl alcohol isamyl ether,vanillyl alcohol n-hexyl ether, vanillyl alcohol methyl ether, vanillylalcohol ethyl ether, ginerol, shogaol, paradol, zingerone, capsaicin,dihydrocapsaicin, nodihydrocapsaicin, homocapsaicin,homodihydrocapsaicin, ethanol, isopropyl alcohol, iso-amylalcohol,benzyl alcohol, chloroform, eugenol, cinnamon oil, cinnamic aldehyde,and mixtures thereof. Warming agents are preferably used at a level offrom about 0.001 to about 5%, more preferably from about 0.05% to about3.5%, by weight of the composition.

[0097] Preparation of Compositions

[0098] The compositions of the present invention are prepared bystandard techniques well known to those skilled in the art. If thecomposition comprises more than one phase, in general the differentphases will be prepared separately, with materials of similar phasepartitioning being added in any order. The two phases will then becombined with vigorous stirring to form the multiphase system eg anemulsion or dispersion. Any ingredients in the formulation with highvolatility, or which are susceptible to hydrolysis at high temperatures,will usually be added post mixing of the different phases with gentlestirring. If the composition optionally comprises polyphosphate it ispreferred that the polyphosphate is not pre-dispersed in water prior toaddition to the composition in order to prevent hydrolysis. Typicalconfectionery methods are highly suitable for manufacturing ofcompositions of the present invention. Finally if the products arecoated confectionery compositions the coating step is conducted as afinal step. The coating can be applied by panning or spray driedtechniques commonly known to those skilled in the art.

EXAMPLES

[0099] The following examples further illustrate the preferredembodiments within the scope of the present invention. These examplesare given solely for the purpose of illustration and are not to beconstrued as limitations of the present invention as many variations ofthe invention are possible without departing from its spirit or scope.Unless otherwise indicated, all ingredients are expressed as a weightpercentage of the composition. I II III IV V VI INGREDIENT % w/w % w/w %w/w % w/w % w/w % w/w Sugar 36.45 — — — — — Glucose 22.00 — — — — —Gumbase 30.00 30.00 30.00 30.000 30.000 32.000 Sorbitol — 40.95 41.2541.445 40.880 39.660 Xylitol — 20.00 20.00 20.000 20.000 20.000 Glycerin8.00 5.00 5.00 5.000 5.000 5.000 Water 0.50 0.50 0.50 0.500 0.500 0.500Copper — — — — 0.050 — Gluconate Zinc lactate — — — — 0.025 — ZincAcetate 0.50 1.00 — — — 0.24 Zinc Citrate — — 0.65 0.425 — — TinChloride 0.02 0.02 0.02 0.050 — 0.05 Flavour 2.50 2.50 2.50 2.500 2.5002.500 Lecithin 0.03 0.03 0.03 0.030 — — Acesulfam K — — 0.05 0.050 0.0500.050 TOTAL 100.00 100.00 100.00 100.00 100.00 100.00 COATING (20-30%w/w) Sorbitol — — — — 94.80 94.80 Water — — — — 2.00 2.00 Titanium — — —— 1.50 1.50 Dioxide Acesulfam K — — — — 0.05 0.05 Polysorbate 60 — — — —0.15 0.15 Flavour — — — — 1.50 1.50 TOTAL — — — — 100.00 100.00

Examples I-VI

[0100] Chewing gums: Melt gumbase to 55-60° C. in sigma blade mixer. Addin bulk sweetener and glycerin, mix. Add in actives and mix. Mix inflavour last. Remove from heat and allow to cool before moulding andcutting. Coating pre-solution is sprayed onto cooled gum in fine layerswhich are allowed to dry before subsequent layers are added. Sufficientcoating is added such that total coating weight is 20-30% of finalfinished pellet weight. VII VIII IX X XI XII INGREDIENT % w/w % w/w %w/w % w/w % w/w % w/w Gumbase 32.00 30.000 30.00 30.000 — — Sorbitol39.93 38.525 35.83 38.925 — 97.06 Xylitol 20.00 20.000 20.00 20.000 — —Isomalt — — — — 94.28 — Glycerin 5.00 5.000 5.000 5.000 — — Gelatine — —— — — 0.10 Water 0.50 0.500 0.500 0.500 3.00 0.50 Copper 0.01 — — 0.050— — Gluconate Zinc lactate — — — 0.025 — — Zinc Acetate — — — — — 0.24Zinc Citrate — 0.425 0.65 — 0.65 — Tin Chloride 0.01 0.050 0.02 — 0.020.05 Sodium — — — — 1.00 — (n = 6) hexameta- phosphate Sodium — 2.5005.00 — — 1.00 polyphosphate (n = 21) Sodium — — — 2.50 — — BicarbonateFlavour 2.50 2.500 2.50 2.50 1.00 1.00 Acesulfam K 0.05 0.05 0.05 0.050.05 0.05 TOTAL 100.00 100.00 100.00 100.00 100.00 100.00

Examples VII-X

[0101] Chewing gums: Melt gumbase to 55-60° C. in sigma blade mixer. Addin bulk sweetener and glycerin, mix. Add in actives and mix. Mix inflavour last. Remove from heat and allow to cool before moulding andcutting. Coating pre-solution is sprayed onto cooled gum in fine layerswhich are allowed to dry before subsequent layers are added. Sufficientcoating is added such that total coating weight is 20-30% of finalfinished pellet weight.

Examples XI

[0102] Lozenge. Isomalt is dissolved in water and heated under stirringto 110-112° C. Glucose syrup is then added and the mix heated to141-142° C. to boil off water. Batch is drawn down under vacuum andactives/flavours added at approx 90° C. in low humidity environment.Batch is folded on a hot table and subsequently cooled on cold table(20° C.) prior to transfer to the batch forming and die cuttingapparatus. Final product has a Glass like translucent appearance.

Example XII

[0103] Compressed tablet. A pre-formed solution of gelatine and gumproducts is prepared and sprayed over sugar or dextrose or isomalt toform a granular mixture. This is dried and sieved and subsequentlycompressed to form tablets.

[0104] While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. A confectionery composition comprising: (i)greater than about 10 pm of a first metal cation selected from themetals of groups 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 of the periodictable; (ii) greater than about 10 ppm of a second metal cation differentfrom the first metal cation and selected from the metals of groups 5, 6,7, 8, 9, 10, 11, 12, 14, 16 of the periodic table; (iii) less than about10% water; and (iv) a confectionery carrier wherein the ratio of thefirst metal cation to the second metal cation is in the range of fromabout 50:1 to about 1:50.
 2. A confectionery composition according toclaim 1 wherein the first metal cation and second metal cation aremonovalent or divalent cations selected from the group consisting ofzinc, manganese, copper, iron, cobalt, silver, selenium, tin andvanadium.
 3. A confectionery composition according to claim 2 whereinthe first metal cation and second metal cation are selected from thegroup consisting of zinc, manganese, copper, iron, silver, and tin.
 4. Aconfectionery composition according to claim 1 wherein the metal cationis provided as a metal salt selected from the group consisting ofacetate, ammonium sulphate, bromide, chloride, chromate, citrate,dithionate, fluorosilicate, tartrate, fluoride, formate, iodide,nitrate, phenol sulphate, salicyclate, sulphate, gluconate, succinate,glycerophosphate, lactate and mixtures thereof.
 5. A confectionerycomposition according to claim 1 wherein the composition comprisesgreater than about 15 ppm of each of the first metal cation and of thesecond metal cation.
 6. A confectionery composition according to claim 5wherein the composition comprises greater than about 25 ppm of each ofthe first metal cation and of the second metal cation.
 7. Aconfectionery composition according to claim 1 wherein the compositioncomprises from about 0.001% to about 5% of each of the metal saltscomprising the first metal cation and the second metal cation by weightof the composition.
 8. A confectionery composition according to claim 7% wherein the composition comprises from about from about 0.1% to about0.5% of each of the metal salts comprising the first metal cation andthe second metal cation by weight of the composition.
 9. A confectionerycomposition according to claim 1 wherein the molar ratio of the firstmetal cation to the second metal cation is in the range of from about20:1 to about 1:20.
 10. A confectionery composition according to claim 1wherein the molar ratio of the first metal cation to the second metalcation is in the range of from about 10:1 to about 1:10.
 11. Aconfectionery composition according to claim 1 wherein the confectionerycarrier material is selected from chewing gum base, hard boiled candybase, low boiled candy base, gelatine base, compressed sugar base ormixtures thereof.
 12. A confectionery composition according to claim 11wherein the composition comprises greater than about 10% of gum base byweight of the composition.
 13. A confectionery composition according toclaim 12 wherein the composition comprises greater than about 25% of gumbase by weight of the composition.
 14. A confectionery compositionaccording to claim 1 wherein the composition comprises less than about8% water by weight of the composition.
 15. A confectionery compositionaccording to claim 14 wherein the composition comprises less than about2% water by weight of the composition.
 16. A confectionery compositionaccording to claim 1 wherein the composition comprises greater thanabout 10% of non-cariogenic sweetener by weight of the composition. 17.A confectionery composition according to claim 16 wherein thecomposition comprises greater than about 40% of non-cariogenic sweetenerby weight of the composition.
 18. A confectionery composition accordingto claim 16 wherein the non-cariogenic sweetener is a sugar alcoholselected from the group consisting of maltitol, mannitol, xylitol,sorbitol, sucralose, aspartame and mixtures thereof.
 19. A confectionerycomposition according to claim 1 wherein the confectionery compositionhas an outer coating.
 20. A confectionery composition according to claim1 wherein the composition further comprises an oral care active selectedfrom the group consisting of anti-calculus agents; anti-plaque agents;fluoride ion source; desensitising agents; oral malodour control agents;H2 antagonists; and mixtures thereof.
 21. A confectionery compositionaccording to claim 20 wherein the oral care active is selected frompolyphosphates, pyrophosphates, phosphonates, fluoride salts, xylitol,potassium nitrate, and mixtures thereof.
 22. A confectionery compositionaccording to claim 21 wherein the oral care active is a polyphosphatematerial having an average anion chain length of from about 3 to about40.
 23. A confectionery composition according to claim 21 wherein theoral care active is a polyphosphate material having an average anionchain length of from about 18 to about
 25. 24. A confectionerycomposition according to claim 23 wherein the polyphosphate is an alkalimetal or ammonium salt.
 25. A confectionery composition according toclaim 20 wherein the composition comprises from about 0.01% to about 50%of oral care active by weight of the composition.
 26. A confectionerycomposition according to claim 25 wherein the oral care active isdispersed throughout the core of the confectionery composition and oneor more of the metal cations are dispersed throughout the coat of thecomposition.
 27. A confectionery composition according to claim 1wherein the composition further comprises an anti-microbial agentselected from the group consisting of chlorhexidine, triclosan, naturalextracts, cetyl pyridinium chloride, hexamidine, hexetidine and mixturesthereof.